Traumatic Brain Injury Clinical Trial
Official title:
Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients
NCT number | NCT05081063 |
Other study ID # | 5210170 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | March 5, 2022 |
Est. completion date | May 15, 2023 |
Verified date | February 2024 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group
Status | Completed |
Enrollment | 201 |
Est. completion date | May 15, 2023 |
Est. primary completion date | May 15, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - all adult male patients brought into the emergency department as LEVEL A trauma activations who are receiving emergency blood transfusions Exclusion Criteria: - Female patients (specifically excluded due to risk of alloimmunization of Rh-negative female patients of childbearing age against Rh-positive blood) - children - prisoners - all patients classified as dead upon arrival to the trauma bay |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Health | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum In: Ann Surg. 2014 Jul;260(1):178. — View Citation
Hanna K, Bible L, Chehab M, Asmar S, Douglas M, Ditillo M, Castanon L, Tang A, Joseph B. Nationwide analysis of whole blood hemostatic resuscitation in civilian trauma. J Trauma Acute Care Surg. 2020 Aug;89(2):329-335. doi: 10.1097/TA.0000000000002753. — View Citation
Murphy C, Silva de Leonardi N. The use of low-titer group O whole blood is independently associated with improved survival compared to component therapy in adults with severe traumatic hemorrhage. Transfusion. 2021 Apr;61(4):1341-1342. doi: 10.1111/trf.16266. No abstract available. — View Citation
Seheult JN, Anto V, Alarcon LH, Sperry JL, Triulzi DJ, Yazer MH. Clinical outcomes among low-titer group O whole blood recipients compared to recipients of conventional components in civilian trauma resuscitation. Transfusion. 2018 Aug;58(8):1838-1845. doi: 10.1111/trf.14779. Epub 2018 Aug 30. — View Citation
Williams J, Merutka N, Meyer D, Bai Y, Prater S, Cabrera R, Holcomb JB, Wade CE, Love JD, Cotton BA. Safety profile and impact of low-titer group O whole blood for emergency use in trauma. J Trauma Acute Care Surg. 2020 Jan;88(1):87-93. doi: 10.1097/TA.0000000000002498. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pRBC equivalents transfused | assessment of pRBC equivalents transfused in each arm, an increase in HGB by 1g/dl per unit transfused will be considered successful
A blood draw of 5ml will be obtained and tested to assess HGB level. An increase in HGB by 1g/dl per unit transfused will be considered a successful result. |
24 hours post ED admission | |
Secondary | Mortality | Assessment of mortality
This is a composite measurement which includes the following in order to be assessed as pulseless with no respiratory drive or brain death: there is no evidence of arousal or awareness to maximal external stimuli pupils are fixed in a midsized or dilated position and non reactive to light corneal, oculocephalic and oculovestibular reflexes are absent There is no facial movement to noxious stimuli the gag reflex is absent to bilateral posterior pharyngeal stimuli the cough reflex is absent to deep tracheal suctioning there is no brain mediated motor response to noxious stimuli of the limbs spontaneous respirations are not observed when apnea test targets reach pH <7.30 and PaCO2 >60mmhg |
Change between ED admission date and 24 hours post discharge |
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